Post-Authorization Safety Surveillance Study of Asenapine in Participants With Bipolar Disorder (P08307)
An Observational Post-Authorization Safety Surveillance (PASS) Study of Sycrest® (Asenapine) Among Patients Aged 18 and Older Diagnosed With Bipolar Disorder
2 other identifiers
observational
42
0 countries
N/A
Brief Summary
This study will assess asenapine (Sycrest®) use in participants with bipolar disorder; comparison will be made to the use of risperidone (RISPERDAL®CONSTA®) and olanzapine (Zyprexa®). The occurrence of identified and potential clinically important risks will also be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2013
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2011
CompletedFirst Posted
Study publicly available on registry
December 20, 2011
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2017
CompletedFebruary 4, 2022
February 1, 2022
4.5 years
December 16, 2011
February 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Bipolar Disorder with Identified and Potential Clinically Important Risks
Identified and potential clinically important risks will include: extrapyramidal symptoms, somnolence and sedation, neuroleptic malignant syndrome, rhabdomyolysis, seizure, hyperprolactinaemia, orthostatic hypotension, neutropenia, allergic reactions, dyslipidaemia and diabetes mellitus with the use of asenapine versus risperidone or olanzapine
Approximately 1 year
Secondary Outcomes (2)
Number of Participants with Schizophrenia with Identified and Potential Clinically Important Risks
Approximately 1 year
Number of Participants without Diagnoses of Schizophrenia or Bipolar Disorder with Identified and Potential Clinically Important Risks
Approximately 1 year
Study Arms (3)
Asenapine
Participants prescribed asenapine
Risperidone Comparator
Participants prescribed risperidone
Olanzapine Comparator
Participants prescribed olanzapine
Eligibility Criteria
Participants with Bipolar Disorder codes who are included in the United Kingdom Clinical Practice Research Datalink (CPRD) and, if required, The Health Improvement Network (THIN) database. If pre-specified sample size and exposure criteria are met, secondary objectives will be conducted in 2 separate study populations: 1. Participants treated with asenapine and diagnosed with schizophrenia and no prior and/or concomitant diagnosis of bipolar disorder; 2. Participants treated with asenapine with no prior and/or concomitant diagnoses of bipolar disorder or schizophrenia, but diagnosed with i) Alzheimer's disease, ii) other diagnoses - mental disorders or iii) no diagnosis.
You may qualify if:
- A diagnosis of Bipolar Disorder
You may not qualify if:
- None
- A diagnosis of schizophrenia
- A prior and/or concomitant diagnosis of bipolar disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2011
First Posted
December 20, 2011
Study Start
July 1, 2013
Primary Completion
December 18, 2017
Study Completion
December 18, 2017
Last Updated
February 4, 2022
Record last verified: 2022-02